BEUDAMED
    Product Code: PAY FDA class 2 21 CFR 878.4420

    Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

    General, Plastic Surgery

    The Over-The-Counter Radiofrequency Coagulation Device for Wrinkle Reduction is an electrosurgical aesthetic device that uses radiofrequency (RF) energy to produce localized heating within tissues for non-invasive cosmetic use. It falls under the General and Plastic Surgery medical specialty and is classified as a Class 2 device under regulation 878.4420, requiring 510(k) premarket notification. As an over-the-counter device, it is subject to general controls and special controls but does not require a prescription. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    12
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    5
    Years Active
    10

    Research product code PAY in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    PAY
    Device Class
    FDA class 2
    Regulation Number
    878.4420
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 12 510(k) clearances via K numbers.

    K Number Device Name
    K250341 Sensilift Pro (ST300XXYYZZZ)
    K242227 GENEO X ELITE
    K240616 FAQ™ (102)
    K233766 Geneo X Elite
    K232424 CurrentBody Skin RF
    K230013 Silk'n Titan Allways
    K220322 Pollogen STOP U Model UXV Device
    K222012 FAQ 101
    K203665 STOP U Model UXV Device
    K182774 STOP U (Packed Black USA), STOP U (Packed White USA)
    K170499 sensiLift
    DEN150005 Newa Skin Therapy System

    FEI Numbers

    This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.